1. First‐line pembrolizumab for non–small cell lung cancer patients with PD‐L1 ≥50% in a multicenter real‐life cohort: The PEMBREIZH study
- Author
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Karim Amrane, Gilles Robinet, Ronan Abgral, Gilles Quere, Jean-Louis Bizec, Éric Goarant, Sylvie Gouva, Cyril Bernier, Renaud Descourt, R. Lamy, Hervé Lena, Guillaume Léveiller, Florence Gadby, Ulrike Schick, Margaux Geier, Romain Corre, Christos Chouaid, CHRU Brest, F-29200 Brest, France, Hôpital de la Cavale Blanche - CHRU Brest (CHU - BREST ), Hôpital Morvan - CHRU de Brest (CHU - BREST ), Centre Hospitalier Intercommunal de Cornouaille [Quimper] (CHI Cornouaille [Quimper]), Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Yves le Foll, CH des Pays Morlaix, CH Bretagne Sud, CH Bretagne Atlantique, CH de Saint-Malo, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CHRU Brest - Service de médecine nucléaire (CHU - BREST - Med Nucléaire), Laboratoire de Traitement de l'Information Medicale (LaTIM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-IMT Atlantique (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Centre hospitalier Rene Pleven de Dinan, Biomécanique cellulaire et respiratoire (BCR), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Centre National de la Recherche Scientifique (CNRS), Service de Pneumologie [CHI Créteil], CHI Créteil, IMRB - CEPIA/'Clinical Epidemiology And Ageing : Geriatrics, Primary Care and Public Health' [Créteil] (U955 Inserm - UPEC), Institut Mondor de Recherche Biomédicale (IMRB), and Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)
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Male ,0301 basic medicine ,Oncology ,Cancer Research ,Longitudinal study ,Lung Neoplasms ,Pembrolizumab ,B7-H1 Antigen ,Antineoplastic Agents, Immunological ,0302 clinical medicine ,non–small cell lung cancer ,Carcinoma, Non-Small-Cell Lung ,PD‐L1 tumor proportion score ,Longitudinal Studies ,Original Research ,Aged, 80 and over ,biology ,Real world ,Middle Aged ,Prognosis ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Survival Rate ,030220 oncology & carcinogenesis ,Cohort ,Female ,pembrolizumab ,Adult ,medicine.medical_specialty ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,Antibodies, Monoclonal, Humanized ,lcsh:RC254-282 ,PD-L1 tumor proportion score ,03 medical and health sciences ,PD-L1 ,Internal medicine ,medicine ,Humans ,first‐line monotherapy ,Radiology, Nuclear Medicine and imaging ,Lung cancer ,Adverse effect ,non-small cell lung cancer ,Aged ,Retrospective Studies ,Performance status ,business.industry ,Clinical Cancer Research ,medicine.disease ,Clinical trial ,030104 developmental biology ,biology.protein ,first-line monotherapy ,business ,Follow-Up Studies - Abstract
Background The KEYNOTE‐024 trial demonstrated that pembrolizumab, a PD‐1 inhibitor, significantly improves progression‐free survival (PFS) and overall survival (OS) in selected patients with previously untreated advanced non–small cell lung cancer (NSCLC) with a PD‐L1 tumor proportion score (TPS) ≥50% and without EGFR/ALK aberrations. The main aim of this study was to report the efficacy and safety profile of pembrolizumab in real‐life conditions. Method This was a French retrospective multicenter longitudinal study of 108 consecutive patients with advanced NSCLC, a PD‐L1 TPS ≥50% and without EGFR/ALK aberrations who were treated by pembrolizumab, in first line. Patient data were obtained from medical files. Results The main characteristics of the cohort were: median age [range] 66.7 [37‐87] years, 64.8% male, 23.1% with a performance status (PS) of 2, and 88.9% current or former smokers. Eighty‐seven percent had stage IV NSCLC at diagnosis, 9.2% untreated brain metastases at inclusion,. With a median follow‐up of 8.2 months, the median PFS was 10.1 months (95% CI, 8.8‐11.4). The objective response rate was 57.3% (complete response 2.7%, partial response 54.6%). Disease control rate was 71.1%. At 6 months, the OS rate estimated was 86.2%. Treatment‐related adverse events (AE) of grade 3 occurred in 8% of patients. There were no grade 4 or 5 AEs. Conclusion In a real‐life cohort of advanced NSCLC patients (including PS 2 and untreated brain metastases), with PD‐L1 TPS ≥50%, pembrolizumab demonstrates similar PFS to the pivotal clinical trial., This retrospective multicenter longitudinal study was intended to report the efficacy and safety profile of pembrolizumab in real‐life conditions for the first‐line treatment of advanced squamous none small‐cell lung cancer. The median progression free survival was 10.1 months (95% CI, 8.8‐11.4) and the treatment‐related adverse events of grade 3 occurred in 8% of patients. This study demonstrates similar progression‐free survival to KEYNOTE‐024.
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- 2020